Friday, October 23, 2009

CDC advisory committee recommends Cervarix HPV vaccine for girls, young women to prevent cervical cancer

Philadelphia, PA
GlaxoSmithKline
announced today that the U.S. Centers for Disease Control and Prevention's (CDC's) Advisory Committee on Immunization Practices (ACIP) recommended that CERVARIX® [Human papillomavirus bivalent (types 16 and 18) vaccine, recombinant] be given to girls and young women to protect against cervical pre-cancers and cervical cancer caused by oncogenic HPV 16 and 18. The ACIP specifically recommended CERVARIX for routine administration among 11 and 12 year old girls. In addition, the recommendation includes a catch up for girls and young women who have not previously been vaccinated, which for the approved age range for CERVARIX includes 13-25 year old girls and young women.

On October 16, 2009, the Food and Drug Administration (FDA) approved CERVARIX for the prevention of cervical pre-cancers and cervical cancer associated with oncogenic human papillomavirus (HPV) types 16 and 18 for use in girls and young women (aged 10-25).

"It's estimated that this year, ten women will die every day from cervical cancer in the U.S.," said Barbara Howe, M.D., Vice President and Director, North American Vaccine Development, GlaxoSmithKline. "The ACIP recommendation for CERVARIX underscores how important it is for girls and young women to be vaccinated to help reduce the burden of this devastating cancer."

Additionally, the ACIP unanimously recommended to provide funding for CERVARIX from the Vaccines for Children (VFC) program. The federally funded program provides vaccines at no cost to children up through 18 years of age who might not otherwise be vaccinated because of inability to pay. Children who are eligible for VFC vaccines are entitled to receive pediatric vaccines that are recommended by the ACIP.

CERVARIX is expected to be commercially available in the U.S. in late 2009.

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